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Food and Drug Regulations

Version of section C.08.007 from 2006-03-22 to 2011-03-24:

 Where a manufacturer has received a notice of compliance issued in respect of a new drug submission or abbreviated new drug submission or a supplement to either submission, the manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting

  • (a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug;

  • (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug;

  • (c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug;

  • (d) any substitution of another substance for that new drug or any mixing of another substance with that new drug;

  • (e) any error in the labelling of that new drug or in the use of the labels designed for that new drug;

  • (f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug;

  • (g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and

  • (h) any unusual failure in efficacy of that new drug.

  • (i) [Repealed, SOR/95-521, s. 3]

  • SOR/95-411, s. 10
  • SOR/95-521, s. 3

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